Risk Assessment Of Wheat Allergy Associated With Pre-packaged Foods

Food allergy represents a significant concern within both public health and food safety domains.In the realm of food safety,a leading-edge paradigm involves evaluating the safety of food products by assessing the associated risks.This entails determining whether the level of risk falls within acceptable parameters.The primary method for achieving this evaluation is through scientific risk assessment processes.This study assesses the risk of wheat allergy in pre-packaged foods based on risk assessment principle.First,an evidence-based medicine approach was used to identify the current hazard of wheat allergy;second,the distribution of allergen exposure in pre-packaged foods was analyzed by reviewing allergen labeling;subsequently,wheat allergy risk of pre-packaged foods was predicted by a deterministic risk assessment and quantitative risk approach;and lastly,the potential of implementing wheat allergen labeling exemptions for different categories of foods was analyzed based on the risk assessment approach.The main methods,results and conclusions of the study are presented below:1.The prevalence of wheat allergy was analyzed by using Meta-analysis to scientifically understand the hazard of wheat allergy.Literature related to wheat allergy published between 2007 and 2022 was collected from Web of Science,Pub Med,Ovid LWW and Cochrane databases,and 160,864 articles were finally collected.After a cascade screening process by two independent reviewers,56 highquality literatures were finally included for Meta-analysis of wheat allergy prevalence.The analysis showed that the prevalence of self-reported(SR)wheat allergy was0.63%(95% CI: 0.43%-0.87%),the prevalence of self-reported-physician-diagnosed(SRPD)wheat allergy was 0.70%(95% CI: 0.18%-1.22%),the prevalence of skin prick test(SPT)-positive wheat allergy prevalence was 0.22%(95% CI: 0.07%-0.65%),specific Ig E(s Ig E)-positive wheat allergy prevalence was 0.97%(95% CI:0.43%-2.20%),and food challenge positive wheat allergy prevalence was 0.04%(95% CI: 0%-0.16%).In addition,subgroup analysis indicated that age,basic economic condition,and geographic location may be the main factors influencing wheat allergy.Currently,the hazard of wheat allergy cannot be ignored,and scientific measures are needed to prevent and manage the problem of wheat allergy,both in the field of public health and food safety.2.Prepackaged foods were randomly sampled from five supermarkets and four retail stores in Nanchang City.They were categorized based on the Classification Catalogue of Food Production License issued by the China General Administration of Market Supervision and Administration.Information regarding food ingredients and allergen labeling was recorded for analysis.Gluten in these foods was quantified using ELISA test kits certified by the American Association of Analytical Chemists(AOAC).A total of 575 prepackaged food products across 16 categories were collected.Analysis revealed that 274 products had summary allergen labeling,20 had precautionary allergen labeling(PAL),125 had both,and 156 lacked allergen labeling.Major allergens included wheat/gluten,milk,and soy,regardless of labeling type.ELISA tests detected more than 20 ppm gluten in 297 products.Analysis of allergen labeling alongside ELISA results indicated that around 20% of products were improperly labeled for wheat-related allergens.Allergen labeling,as an important risk communication tool,incorrectly used may cause unexpected allergic reactions in allergic consumers,thus necessitating a scientific assessment of the risk of wheat allergy in prepackaged foods.3.Given the importance of wheat allergy and the issue of mislabeling wheat-related allergens in prepackaged foods,our study first screened foods with PAL and those incorrectly labeled for allergens.Then,we assessed the action levels using the Voluntary Incidental Trace Allergen labeling(VITAL)program and evaluated their risk through deterministic risk assessment methodology.123 food items were identified for further analysis.The results of VITAL program indicated that 50 prepackaged foods,lacking wheat-related PAL labels and rated at action level 2,could potentially trigger allergic reactions in wheat-allergic individuals.For the deterministic risk assessment,the consumption of prepackaged foods was fitted by Log-Normal,Weibull and Gamma models,determining 95% quartile consumption levels of 137.93 g,134.62 g,and 163.11 g,respectively.Based on the related consumption level,the assessment of wheat allergy risk was carried out.The LogNormal,Weibull and Gamma models showed that the number of pre-packaged foods at risk was 82,76 and 77,respectively.Incorrect use of wheat allergen labeling can put prepackaged foods at risk,suggesting that food companies should strengthen wheat allergy risk management and use wheat allergen labeling through scientific procedures.4.In order to achieve risk communication and continuous risk monitoring of wheat allergy,the quantitative risk assessment methodology was used in this study.Initially,prepackaged foods with potential wheat ingredients were screened based on ELISA test results,allergen labels,and ingredient lists.Then,gluten protein concentration and food consumption data were fitted by Log-Normal,Weibull,and Gamma models to establish distributions.These distributions,along with Monte Carlo simulation and function modeling,were used to establish the distribution of wheat protein intake in the population.Subsequently,relevant distributions were established based on published data on wheat allergy thresholds,and the Monte Carlo simulation method was employed to quantify the risk of wheat allergic reactions.The study identified 37 prepackaged foods containing undisclosed wheat ingredients.Results indicated that,based on 10,000 simulated eating occasions,the Log-Normal model predicted an average of 682 wheat allergic reactions,the Weibull model predicted 854 reactions,and the Gamma model predicted 677 reactions.These findings provide a quantitative understanding of wheat allergy risk,which can correct misconceptions among allergic individuals and regulatory bodies,while also reducing uncertainty in food safety assessments.5.The evaluation of the wheat allergy risk of 13 categories of prepackaged foods was assessed using both deterministic and quantitative risk assessment methodology,aiming to provide scientific evidence to support the policy of wheat allergen labeling exemption.In the deterministic risk assessment,the 95% quartiles of prepackaged food consumption predicted based on the Log-Normal model ranged from 60.61 g to999.60 g,while those based on the Weibull model ranged from 69.80 g to 635.97 g,and those based on the Gamma model ranged from 78.72 g to 673.36 g.The results of deterministic risk assessment showed that the Biscuit products consistently posed a risk of allergic reaction,while the Egg products showed no such risk.Other food categories varied in their risk levels.Under the quantitative risk assessment,the LogNormal,Weibull,and Gamma models were used to establish the distribution of wheat protein intake in the population.Incorporating to wheat allergen threshold distribution,the mean risk of wheat allergy within 10,000 simulated eating occasions was assessed.According to the Log-Normal and Weibull models,the Biscuit products presented the highest mean risk,with around 8,500 to 8,900 anaphylactic reactions.The Bakery products showed the highest mean risk according to the Gamma model.Egg products consistently showed the lowest risk across all models.The deterministic and quantitative assessment of wheat allergy risk in different categories of prepackaged foods indicated that the Egg products have the potential to implement wheat allergen labeling exemptions.In summary,this study employed advanced risk assessment methodologies to analyze the hazards of wheat allergy,the exposure of wheat allergens in pre-packaged foods,and the associated risk levels.It highlights the importance of conducting such assessments for pre-packaged foods in China.Additionally,the study applied these methodologies to investigate exemptions in wheat allergen labeling,emphasizing that a comprehensive food allergen risk assessment will help to promote the formulation and updating of food regulations and standards in China,as well as improve the food safety management system.